Implant placement method with feedback

ABSTRACT

Methods for performing orthopaedic surgical procedures using a handheld scanner are disclosed. The methods include, generally, performing one or more intra-operative scans using a handheld scanner, generating scan data from the intra-operatives scans, and comparing the scan data to a surgical plan. The scan data and other feedback data are used to validate the position and orientation of orthopaedic prosthetic component implanted in a body of the patient.

TECHNICAL FIELD

The present disclosure relates generally to methods for performingorthopaedic surgical procedures and, more particularly, to methods thatuse intra-operative scans made using a hand-held device.

BACKGROUND

Joint arthroplasty is a well-known surgical procedure by which adiseased and/or damaged natural joint is replaced by a prosthetic joint.For example, in a hip arthroplasty surgical procedure, a patient'snatural hip ball and socket joint is partially or totally replaced by aprosthetic hip joint. A typical prosthetic hip joint includes anacetabular prosthetic component and a femoral head prosthetic component.An acetabular prosthetic component generally includes an outer shellconfigured to engage the acetabulum of the patient and an inner bearingor liner coupled to the shell and configured to engage the femoral head.The femoral head prosthetic component and inner liner of the acetabularcomponent form a ball and socket joint that approximates the natural hipjoint.

To facilitate the replacement of the natural joint with a prosthetic hipjoint, orthopaedic surgeons may use a variety of orthopaedic surgicalmethods such as, for example, trialing, to determine if an orthopaedicimplant is positioned correctly in the patient.

SUMMARY

According to one aspect of the disclosure, a method of performing anorthopaedic surgical procedure on a patient is disclosed. The methodincludes positioning the patient on a surgical table in an operatingroom and making an incision in the patient's tissue to expose a bone ofthe patient. A hand-held device is used to obtain a first scan, thefirst scan including a position and an orientation of the bone in theoperating room. The hand-held device transmits the first scan to acomputing device. A member of the surgical team operates the computingdevice to compare the position and the orientation of the bone includedin the first scan to a surgical plan including a planned position and aplanned orientation of the patient's bone and to generate an adjustedplanned position and an adjusted planned orientation of an orthopaedicprosthetic component in the patient's bone based on the position and theorientation of the bone included in the first scan. An orthopaedicprosthetic component is implanted in the bone of the patient. A secondscan is obtained with the hand-held device, the second scan including aposition and an orientation of the orthopaedic prosthetic component inthe bone. The hand-held device transmits the second scan to thecomputing device. A member of the surgical team operates the computingdevice to confirm that the position and the orientation of theorthopaedic prosthetic component included in the second scan matches theadjusted planned position and the adjusted planned orientation of theorthopaedic prosthetic component.

The first scan may further comprise positioning an optical detector ofthe hand-held device inside of the incision formed in the patient'stissue, and performing the first scan with the hand-held device.

The hand-held device may further comprise an optical detector positionedon the hand-held device, the optical detector being configured to detectelectromagnetic radiation reflected from a surface of interest on thepatient. The hand-held device may be a white light scanner configured todetermine one or more locations of a surface of interest on the patientby detecting one or more characteristics of white light reflected fromthe surface of interest. The hand-held device may be a laser scannerthat includes one or more optical detectors configured to determine oneor more locations on a surface of interest on the patient by detectingone or more characteristics of laser light reflected from the surface ofinterest.

When obtaining scans using the hand-held device the patient is not movedto a new location and the position of the patient relative to areference plane is not modified.

Operating the computing device may further comprises operating thecomputing device to display a comparison of the position and theorientation of the bone included in the first scan to the surgical planthat includes the planned position and the planned orientation of thepatient's bone. Operating the computing device may also further compriseoperating the computing device to display a comparison of the positionand orientation of the orthopaedic prosthetic component included in thesecond scan to the surgical plan that includes the planned componentposition and planned component orientation of the orthopaedic prostheticcomponent in the patient's bone.

The orthopaedic surgical procedure may further include positioning anorthopaedic trialing component in the bone of the patient. The hand-helddevice is used to obtain a third scan, the third scan including a firstposition and a first orientation of the orthopaedic trialing component.The hand-held device transmits the third scan to the computing device. Amember of the surgical team operates the computing device to determinetrialing feedback data by comparing the first position and the firstorientation of the orthopaedic trialing component included in the thirdscan to the surgical plan that includes a planned component position anda planned component orientation of the orthopaedic prosthetic component.

The orthopaedic surgical procedure may further include adjusting theorthopaedic trialing component to be in a second position and a secondorientation in the bone of the patient based on the trialing feedbackdata. The hand-held device is used to obtain a fourth scan, the fourthscan including data related to the second position and the secondorientation of the orthopaedic trialing component. A member of thesurgical team operates the computing device to determine additionaltrialing feedback data by comparing the second position and the secondorientation of the orthopaedic trialing component included in the fourthscan to the surgical plan.

The orthopaedic surgical procedure may yet further include selecting adifferent orthopaedic trialing component based on the trialing feedbackdata and positioning the different orthopaedic trialing component in thebone of the patient. The hand-held device is used to obtain a fifthscan, the fifth scan including a position and an orientation of thedifferent orthopaedic trialing component. The hand-held device transmitsthe fifth scan from the hand-held device to the computing device. Amember of the surgical team operates the computing device to compare theposition and orientation of the different orthopaedic trialing componentincluded in the fifth scan to the surgical plan.

In some embodiments, the hand-held device may transmit each of the scansto the computing device wirelessly.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a patient includes positioning the patient on asurgical table in an operating room and making an incision in thepatient's tissue to expose a bone of the patient. A hand-held device isused to obtain a first scan, the first scan including a position and anorientation of the bone in the operating room, and transmits the firstscan to a computing device. A member of the surgical team operates thecomputing device to compare the position and the orientation of the boneincluded in the first scan to a surgical plan including a plannedposition and a planned orientation of the patient's bone and to generatean adjusted planned position and an adjusted planned orientation of anorthopaedic prosthetic component in the patient's bone based on theposition and the orientation of the bone included in the first scan. Anorthopaedic trialing component is positioned in the bone of the patientbased on the adjusted planned position and the adjusted plannedorientation. The hand-held device is used to obtain a second scan, thesecond scan including a first position and a first orientation of theorthopaedic trialing component, and transmit the second scan to thecomputing device. A member of the surgical team operates the computingdevice to determine trialing feedback data by comparing the firstposition and the first orientation of the orthopaedic trialing componentincluded in the second scan to the surgical plan that includes a plannedcomponent position and a planned component orientation of theorthopaedic prosthetic component.

The orthopaedic surgical procedure may further include adjusting theorthopaedic trialing component to be in a second position and a secondorientation in the bone of the patient based on the trialing feedbackdata. The hand-held device is used to obtain a third scan, the thirdscan including data related to the second position and the secondorientation of the orthopaedic trialing component and transmitting thethird scan from the hand-held device to the computing device. A memberof the surgical team operating the computing device to compare thesecond position and the second orientation of the orthopaedic trialingcomponent included in the third scan to the surgical plan.

The orthopaedic surgical procedure may further include selecting adifferent orthopaedic trialing component based on the trialing feedbackdata, and positioning the different orthopaedic trialing component inthe bone of the patient. The hand-held device being used to obtain afourth scan, the fourth scan including a position and an orientation ofthe different orthopaedic trialing component, and transmitting thefourth scan from the hand-held device to the computing device. A memberof the surgical team operating the computing device to determiningadditional trialing feedback data by comparing the position andorientation of the different orthopaedic trialing component included inthe fourth scan to the surgical plan.

In some embodiments, the orthopaedic trialing component is positioned inthe bone of the patient prior to implanting the orthopaedic prostheticcomponent in the bone of the patient. In such an embodiment, theorthopaedic prosthetic component is positioned in the bone of thepatient based on the trialing feedback data.

The orthopaedic surgical procedure may include selecting a size oforthopaedic trialing component based on the position and the orientationof the bone included in the first scan, the size of the orthopaedictrialing component being different than the size of the orthopaedictrialing component specified in the surgical plan.

In some embodiments, the hand-held device may transmit each of the scansto the computing device wirelessly.

According to another aspect, a method of performing an orthopaedicsurgical procedure on a patient includes positioning the patient on asurgical table in an operating room, making an incision in the patient'stissue to expose a bone of the patient, and positioning an orthopaedictrialing component in the bone of the patient based on a surgical planthat includes a planned position, and a planned orientation. A hand-helddevice is used to obtain a first scan, the first scan including a firstposition and a first orientation of the orthopaedic trialing component,and to transmit the first scan from the hand-held device to a computingdevice. A member of the surgical team operates the computing device todetermine trialing feedback data by comparing the first position and thefirst orientation of the orthopaedic trialing component included in thefirst scan to the surgical plan, and to implant an orthopaedicprosthetic component in the bone of the patient. The hand-held device isused to obtain a second scan, the second scan including a componentposition and a component orientation of the orthopaedic prostheticcomponent in the bone, and to transmit the second scan from thehand-held device to the computing device. A member of the surgical teamoperates the computing device to confirm that the component position andthe component orientation of the orthopaedic prosthetic componentincluded in the second scan matches the planned position and the plannedorientation of the orthopaedic prosthetic component.

The orthopaedic surgical procedure may further include having a memberof the surgical team operating the computing device to determine anadjusted position and an adjusted orientation based on the trialingfeedback data, implanting the orthopaedic prosthetic component in thebone of the patient in the adjusted position and in the adjustedorientation, and operating the computing device to confirm that thecomponent position and the component orientation of the orthopaedicprosthetic component included in the second scan matches the adjustedposition and the adjusted orientation.

In some embodiments, the adjusted position determined from the trialingfeedback data is different than the planned position included in thesurgical plan and the adjusted orientation determined from the trialingfeedback data is different than the planned orientation included in thesurgical plan.

In some embodiments, the surgical plan further includes a plannedprosthetic size. In such embodiments, the orthopaedic surgical proceduremay further include selecting the orthopaedic trialing component basedon the planned prosthetic size included in the surgical plan. A memberof the surgical team may operate the computing device to compare thefirst position and the first orientation of the orthopaedic trialingcomponent included in the first scan to determine a new prosthetic size,and select the orthopaedic prosthetic component to implant in the boneof the patient based on the new prosthetic size.

In some embodiments, the hand-held device may transmit each of the scansto the computing device wirelessly.

According to another aspect, a method of performing an orthopaedicsurgery on a patient includes positioning the patient on a surgicaltable in an operating room, making an incision in the patient's tissueto expose a bone of the patient, obtaining a first scan with a hand-helddevice, the first scan including a position and an orientation of thebone in the operating room, transmitting the first scan from thehand-held device to a computing device, and operating the computingdevice to (i) compare the position and the orientation of the boneincluded in the first scan to a surgical plan including a plannedposition and a planned orientation of the patient's bone and (ii)generate an adjusted planned position and an adjusted plannedorientation of an orthopaedic prosthetic component in the patient's bonebased on the position and the orientation of the bone included in thefirst scan.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the following figures,in which:

FIG. 1 is a simplified block diagram of one embodiment of a system forperforming intra-operative scans on a patient during an orthopaedicsurgical procedure;

FIG. 2 is a simplified flow diagram of an embodiment of a method forperforming the orthopaedic surgical procedure of FIG. 1;

FIG. 3 is a simplified flow diagram for determining the position andorientation of the bone of the patient during the orthopaedic surgicalprocedure;

FIGS. 4-5 are a simplified flow diagram for performing a trialingprocedure during the orthopaedic surgical procedure;

FIG. 6-7 are a simplified flow diagram for implanting an orthopaedicprosthetic component and confirming that the position and orientation ofthe orthopaedic prosthetic component matches the surgical plan;

FIG. 8 is a plan view of a planned bone alignment of the patient and aplanned implantation angle of the orthopaedic prosthetic component to beused during the orthopaedic surgical procedure of FIG. 1;

FIG. 9 is a plan view of an actual bone alignment of the patient and anadjusted implantation angle of the orthopaedic prosthetic component tobe used during the orthopaedic surgical procedure of FIG. 1; and

FIG. 10 is a plan view of the bone of the patient comparing the plannedposition and orientation of an orthopaedic component to the actualposition and orientation of the orthopaedic component.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been shown by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the concepts of the present disclosure tothe particular forms disclosed, but on the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

Terms representing anatomical references, such as anterior, posterior,medial, lateral, superior, inferior, etcetera, may be used throughoutthe specification in reference to the orthopaedic implants and surgicalinstruments described herein as well as in reference to the patient'snatural anatomy. Such terms have well-understood meanings in both thestudy of anatomy and the field of orthopaedics. Use of such anatomicalreference terms in the written description and claims is intended to beconsistent with their well-understood meanings unless noted otherwise.

Referring to FIG. 1, a surgical feedback system 100 is configured toperform one or more intra-operative scans. The surgical feedback system100 comprises a hand-held device 110 connected to a computing device 140via a network 170. The hand-held device 110 is configured to generatescan data of a surface of interest on a patient 180 during anorthopaedic surgical procedure. The surface of interest on the patient180 includes an exposed bone 810 of the patient 180 and a surgicalregion around the exposed bone 810 (see FIG. 10). From the scan datagenerated by the hand-held device 110, the surgical feedback system 100may be configured to identify an orientation of the patient's bone 810,compare a current position of the patient's bone 810 to a plannedposition included in a surgical plan (see FIGS. 8 and 9), determine animplantation angle of an orthopaedic surgical component, and/ordetermine a position and an orientation of the orthopaedic surgicalcomponent implanted in the patient 180 (see FIG. 10).

The hand-held device 110 includes a housing 112 and a handle 114configured to be graspable by a user of the hand-held device 110. Thehand-held device 110 also includes one or more optical devices 116, 118,120 and a communication subsystem 122. In the illustrative embodiment,the hand-held device 110 is a three-dimensional white light scanner. Theone or more optical devices 116, 118, 120 are configured to scan thesurface of a patient's bone 810 to generate scan data of the surfaceusing electromagnetic radiation. The optical devices 116, 118, 120 mayinclude at least one emitter 116, at least two detectors 118, 120. Theemitter(s) 116 are configured to illuminate one or more points on thesurface of interest with electromagnetic radiation (i.e., light). Thedetectors 118, 120 are configured to detect the electromagneticradiation reflected by the surface of interest. The emitter(s) 116 maybe embodied as a laser, a light emitting diode, an infrared emitter, orany other type of electromagnetic radiation source. The at least twodetectors 118, 120 may be embodied as a camera, a charge-coupled device(CCD), phototransistor, or another type of sensor configured to detectelectromagnetic radiation. In the illustrative embodiment of FIG. 1, thehand-held device 110 includes one emitter 116 and two detectors 118,120, however, the hand-held device 110 may include any number ofemitters and optical detectors to perform the functions describedherein.

In the illustrative embodiment of FIG. 1, the hand-held device 110 is awhite light scanner configured to determine one or more locations on thesurface of interest on the patient 180 by illuminating the surface ofinterest with white light and determining one or more locations on thesurface of interest based on white light reflected from the surface ofinterest. Specifically, an emitter 116 of the white light scannerilluminates one or more points on the surface of interest with whitelight comprises electromagnetic radiation across a range of frequencies.The detectors 118, 120 receive the white light reflected from thesurface of interest. One or more path length delays of the white lightare determined. Based on the path length delays at different frequenciesof electromagnetic radiation (e.g., visible light), one or morelocations on the surface of interest are determined.

In another embodiment, the hand-held device 110 may be a laser scannerconfigured to illuminate the surface of interest with light emitted froma laser and determine one or more locations on the surface of interestby measuring a time-delay between emission of the light and detection ofthe light and the shape of the light when it is detected. Based on thetime-delay and the shape of the light received by the one or moreoptical detectors, one or more locations on the surface of interest maybe determined. In some embodiments, the time-delays and the shape of thelight detected by different optical detectors is compared when determineone or more positions on the surface of interest.

The communication subsystem 122 of the hand-held device 110 connects thehand-held device 110 to one or more other devices, including thecomputing device 140. The communication subsystem 122 is configured toconnect the hand-held device 110 to one or more networks 170, e.g., alocal area network, wide area network, personal cloud, enterprise cloud,public cloud, a Near Field Communication (NFC) connection, and/or theInternet, for example. Accordingly, the communication subsystem 122 mayinclude one or more short and/or long range wired or wireless (includingoptical) network interface software, firmware, or hardware, for example,as may be needed pursuant to the specifications and/or design of theparticular embodiment of the system 100. The communication subsystem 122may be configured to establish communication using many types ofnetworks 170 and/or network protocols, such as, for example, WiFi, aBLUETOOTH®, or Ethernet communication protocols.

The illustrative computing device 140 is configured to process the scandata generated by the hand-held device 110 and generate feedback data tobe used during an orthopaedic surgical procedure. As described in moredetail below, feedback data may include bone alignment data, trialingfeedback data, or implant feedback data. The computing device 140includes at least one processor 142 (e.g. a microprocessor,microcontroller, digital signal processor, etc.), memory 144, and aninput/output (I/O) subsystem 146. In operation, processor 142 fetchesand executes instructions and information, and generates and transfersinformation to and from other resources coupled to or in datacommunication with the processor 142. The computing device 140 may beembodied as any type of computing device capable of performing thefunctions described herein, such as a personal computer (e.g., desktop,laptop, tablet, smart phone, mobile device, body-mounted device,wearable device, etc.), a server, an enterprise computer system, anetwork of computers, a combination of computers and other electronicdevices, or other electronic devices. Although not specifically shown,it should be understood that the I/O subsystem 146 typically includes,among other things, an I/O controller, a memory controller, and one ormore I/O ports. The processor 142 and the I/O subsystem 146 areconnected to the memory 144. The memory 144 may be embodied as any typeof suitable computer memory device (e.g., volatile memory such asvarious forms of random access memory). In some embodiments, the memory144 is RAM and may temporarily store instructions and data retrievedfrom slower storage devices as needed for current operations, from whichthey can be more quickly read and processed by the processor 142 orother hardware devices. The I/O subsystem 146 is communicatively coupledto a number of hardware and/or software components, including acommunication subsystem 148 and one or more user interface devices 150.It should be understood that each of the foregoing components and/orsystems may be integrated with the computing device 140 or may be aseparate component or system that is in communication with the I/Osubsystem 146 (e.g., over a network 170 or a bus connection).

The communication subsystem 148 is configured to connect the computingdevice 140 to one or more other devices, for example, the hand-helddevice 110. The communication subsystem 148 is similarly embodied as thecommunication subsystem 122 and includes the same functionalitydescribed above. As such, a full description of the communicationsubsystem 148 is not repeated here.

The one or more user interface devices 150 are configured to allow theuser to provide inputs to the computing device 140 and receive outputsfrom the computing device 140. The illustrative embodiment of the one ormore user interface devices 150 includes a display 152 configured todisplay pre-operative data and intra-operative (e.g., feedback data)data to the user. In other embodiments the one or more user interfacedevices may also include a keyboard, a mouse, a touchpad, a touchscreen, one or more speakers, or any other type of input/output device.

Referring to FIG. 2, a method 200 for using the surgical feedback system100 during an orthopaedic surgical procedure is shown. In theillustrative embodiment, the orthopaedic surgical procedure is a jointarthroplasty procedure, such as a hip arthroplasty procedure. In otherembodiments, the orthopaedic surgical procedure may be a kneearthroplasty procedure.

At block 210, pre-operative data for the patient 180 is collected. Asused in this application, “pre-operative data” refers to any data thatis collected prior to performing an orthopaedic surgical procedure andmay be used to generate a surgical plan for the orthopaedic surgicalprocedure. An example of pre-operative data includes pre-operative scandata generated by performing one or more pre-operative scans (at block212). The pre-operative scan data may include data generated by acamera, an x-ray scanner, a CT scanner, an MRI, scanner or datagenerated by other types of imaging devices. Other examples ofpre-operative scan data include one or more pre-operative images, suchas photographs, x-ray images, images generated by a CT scanner, imagesgenerated by an MRI scanner, other images generated by other types ofimaging devices, and/or surgeon preferences.

At block 214, a surgeon, or another member of the surgical team,generates a surgical plan for the orthopaedic surgical procedure basedon the pre-operative data (including the pre-operative scan data). Insome embodiments, the images generated from the pre-operative scans (seeFIG. 10) are used to generate a three-dimensional model of the surfaceof interest on the patient's bone 810.

As used in this application, a “surgical plan” is a set of surgicalparameters for performing the orthopaedic surgical procedure andincludes specifications for placement of the orthopaedic prostheticcomponent and how the orthopaedic prosthetic component should functionin the patient 180. For example, a surgical plan may include a plannedtype of the orthopaedic prosthetic component, a planned size of theorthopaedic prosthetic component, a planned final position of theorthopaedic prosthetic component, a planned final orientation of theorthopaedic prosthetic component (see FIG. 10), a planned position ofthe patient's bone 810 during the orthopaedic surgical procedure (seeFIG. 8), a planned orientation of the patient's bone 810 during theorthopaedic surgical procedure, a planned implantation angle, and/or aplan for a trialing process.

Generating the surgical plan may include determining a number ofdifferent surgical parameters, including parameters about an orthopaedicprosthetic component. The orthopaedic prosthetic component is anartificial device that may be implanted in the body to replace a missingbody part. For example, an acetabular cup prosthesis (see, for example,orthopaedic component 1010 in FIG. 10) may be implanted in a coxal bone810 of the patient 180 in place of the patient's acetabulum. Orthopaediccomponents 1010 may include orthopaedic prosthetic components, which areintended to be implanted in the body, or orthopaedic trialingcomponents, which are intended to only be used during an orthopaedicsurgical procedure. At block 216, a member of the surgical teamdetermines a planned size of the orthopaedic prosthetic component basedon the pre-operative data. The planned size of the orthopaedicprosthetic component may also include a planned type of the orthopaedicprosthetic component. For example, if a hip arthroplasty is beingperformed, a planned size of an acetabular cup prosthetic componentand/or a femoral stem prosthetic component may be chosen. At block 218,based on the pre-operative data, a member of the surgical team selects aplanned final position and a planned final orientation of theorthopaedic prosthetic component in the bone 810.

At block 220, a member of the surgical team determines a plannedposition and a planned orientation of the bone 810 of the patient 180during surgery based on the pre-operative data. At block 222, a plannedimplantation angle of the orthopaedic prosthetic component is determinedbased on the planned final position and orientation of the orthopaedicprosthetic component and the planned position and orientation of thepatient's bone 810 during the orthopaedic surgical procedure. Theplanned implantation angle is configured to provide a reference angle toa surgeon to ensure that the orthopaedic prosthetic component isimplanted correctly given a particular position and orientation of thepatient 180.

During the orthopaedic surgical procedure, at block 224, the patient 180is positioned on a surgical table in an operating room for theorthopaedic surgical procedure. At block 226, a surgeon makes anincision in the patient's tissue to expose a bone of the patient 180. Inthe case of a hip arthroplasty procedure, the exposed bone may be acoxal or pelvic bone of the patient 180 (e.g., bone 810) or a proximalend of a femur. In the case of a knee arthroplasty procedure, theexposed bone may be a distal end of the femur or a proximal end of atibia.

At block 228, during the orthopaedic surgical procedure, a position andan orientation of the patient's bone 810 may optionally be determinedusing one or more intra-operative scans and the pre-operative data. Amore detailed description of block 228 is provided below and is shown inFIG. 3. In some embodiments, the only intra-operative scan performedduring an orthopaedic surgical procedure is a bone alignment scan. Thebone alignment scan configured to determine the tilt of a patient'scoxal bone.

At block 230, during the orthopaedic surgical procedure, a trialingprocedure may optionally be performed using one or more intra-operativescans and the pre-operative data. A more detailed description of block230 is provided below and is shown in FIGS. 4-5.

At block 232, the orthopaedic prosthetic component is implanted and oneor more intra-operative scans of a final position and a finalorientation of the orthopaedic prosthetic component in patient's bodyare performed. The one or more intra-operative scans are used to comparethe planned final position and orientation of the orthopaedic prostheticcomponent to the actual final position and orientation of theorthopaedic prosthetic component. A more detailed description of block232 is provided below and is shown in FIGS. 6-7.

Referring to FIG. 3, a method 228 for determining the position andorientation of the bone 810 of the patient 180 during the orthopaedicsurgical procedure is shown. Before an orthopaedic surgical procedure,the surgical plan is generated, which includes the planned finalposition of the orthopaedic prosthetic component, the planned finalorientation of the orthopaedic prosthetic component, and the plannedimplantation of angle of the orthopaedic prosthetic component. Ingeneral, the planned implantation angle is based on a plannedorientation of the patient 180 during an orthopaedic surgical procedureand the planned final position and orientation of the orthopaedicprosthetic component in the patient 180. The actual position of thepatient 180 in surgery may vary from the planned position of the patient180 used to determine the planned implantation angle. If this is thecase, the implanting the orthopaedic prosthetic component using theplanned implantation angle will not result in the orthopaedic prostheticcomponent being in the planned final position and orientation.

Referring now to FIG. 8, an image generated from data procured in apre-operative scan shows a planned position and a planned orientation ofa bone 810 of the patient 180 during an orthopaedic surgical procedure.In the illustrative embodiment, FIG. 8 depicts a planned position andorientation of a patient's coxal bone 810 during a hip arthroplasty.From the planned position and orientation of the patient's bone 810, aplanned implantation angle α of the orthopaedic component 812 isdetermined and included in the surgical plan. In the illustrativeembodiment, the planned implantation angle α is defined between an axis814 defined by an implantation tool 816 and a reference plane 818.However, other references planes and/or methods of determining animplantation angle may be used. In some embodiments, the implantationtool 816 may use gravity to determine the implantation angle, andtherefore the reference plane 818 may be the ground. In anotherembodiment, the reference plane 818 may be the surgical table.

In contrast, FIG. 9 depicts an actual position and orientation of acoxal bone 810 of the patient 180 during the orthopaedic surgicalprocedure for implanting an orthopaedic component 912. While both FIGS.8 and 9 show alignment of the coxal bone 810 of the patient 180, inother embodiments the position and orientation of other bones of thepatient 180 may be determined (e.g., the femur of the patient 180).

To determine the actual position and orientation of the patient's bone810, at block 310, one or more intra-operative alignment scans of thepatient's bone 810 are performed using the hand-held device 110. Toperform these intra-operative alignment scans, the hand-held device 110may be inserted into the incision formed by the surgeon in the patient180. The one or more intra-operative alignment scans are configured toproduce alignment scan data of the surface of interest on the patient180. In this example, the surface of interest is the exposed bone 810 ofthe patient 180 and the incision made in the patient 180. After theintra-operative alignment scans are performed, the hand-held device 110is configured to transmit the scan data to the computing device 140 overthe network 170. In the illustrative embodiment, network 170 is awireless network and the hand-held device 110 transmits the scan datawirelessly to the computing device 140. In other embodiments, thenetwork 170 may be a wired network. The computing device 140 may beconfigured to use the alignment scan data to generate one or moreimages, one or more three-dimensional models, or other data to output toa member of the surgical team.

In the illustrative embodiment, any of the intra-operative alignmentscans described in this patent application are capable of beingperformed without moving the patient 180. For example, the hand-helddevice 110 may be operated in such a way that it is not necessary tomove the patient 180 to a new location and it is not necessary to movethe patient 180 relative to a reference plane when performing theintra-operative alignment scans. In this way, the intra-operativealignment scans are configured to provide data to the surgical teamwhile minimally affecting the patient 180.

At block 312, bone alignment data is determined based on theintra-operative alignment scan, including determining the actualposition and orientation of the bone 810 during the orthopaedic surgicalprocedure (block 314). As used in this application, “bone alignmentdata” refers to any data generated during surgery that indicates how abone 810 of the patient 180 is positioned and oriented relative to areference plane. Bone alignment data may be generated from the alignmentscan data produced by the one or more intra-operative alignment scans,or data recorded by a member of the surgical team performing theorthopaedic surgical procedure. For example, bone alignment data mayinclude one or more images generated from the intra-operative alignmentscans, data generated by a member of the surgical team performing theorthopaedic surgical procedure, data generated by the computing device140 (including three-dimensional models), or any other type of data thatindicates the position and orientation of the bone 810 of the patient180 during an orthopaedic surgical procedure.

As is shown in FIGS. 8 and 9, the actual position and orientation of thebone 810 of the patient 180 may vary from the planned position andorientation of the patient's bone 810 included in the surgical plan. Atblock 316, a member of the surgical team operates the computing device140 to compare the bone alignment data to the surgical plan. If the bonealignment data does not match the surgical plan, at block 318, thesurgical plan may be adjusted to reflect the actual position andorientation of the patient's bone 810.

If the actual position and orientation of the patient's body varies fromthe position and orientation used to prepare the surgical plan, at block320, a member of the surgical team determines an adjusted implantationangle (e.g., implantation angle β in FIG. 9) based on the bone alignmentdata (e.g., actual position and orientation of the patient's bone 810).The surgical plan is adjusted to include the adjusted implantation angleβ, where the implantation angle β is defined between an axis 914 definedby an implantation tool 816 and a reference plane 818.

In an embodiment, a member of the surgical team operates the computingdevice 140 to display bone alignment data and pre-operative data.Specifically, the one or more images generated from the intra-operativealignment scans may be superimposed on the one or more images generatedfrom the pre-operative scans and displayed on the display 152 of thecomputing device 140. Upon viewing the superimposed images, a user ofthe surgical feedback system 100 may compare the planned position andorientation of the patient's bone 810 to the actual position andorientation of the patient's bone 810 and adjust the surgical planaccording to that comparison.

Referring to FIGS. 4 and 5, a method 230 for performing a trialingprocedure during the orthopaedic surgical procedure is shown. At block410, a member of the surgical team selects an orthopaedic trialingcomponent (see, for example, orthopaedic component 1010 in FIG. 10)based on the surgical plan. The orthopaedic trialing component is usedas part of a trialing procedure to experimentally test the size,position, and orientation of a prosthetic component before implantingthe orthopaedic prosthetic component. The orthopaedic trialing componentis selected based on the planned size and planned type of theorthopaedic prosthetic component included in the surgical plan. In theillustrative embodiment, the orthopaedic trialing component is areusable surgical instrument configured to mimic the size, shape, andfunctionality of a corresponding orthopaedic prosthetic component. Insome embodiments, the surgical plan includes a trialing procedure thatspecifies which planned sizes of orthopaedic trialing components will betested during the surgical procedure.

At block 412, a member of the surgical team positions the orthopaedictrialing component in the patient's bone 810 based on the planned finalposition and planned final orientation of the orthopaedic prostheticcomponent included in the surgical plan. At block 414, one or members ofthe surgical team perform one or more intra-operative trialing scans todetermine a position and an orientation of the orthopaedic trialingcomponent in the patient's exposed bone 810. In the illustrativeembodiment, the intra-operative trialing scans are performed using thehand-held device 110 in such a way that the patient 180 is not moved orrepositioned while the intra-operative trialing scans are performed. Theintra-operative trialing scans are configured to generate trialing scandata of the surface of interest on the patient 180. In this example, thesurface of interest is the patient's exposed bone 810 and theorthopaedic trialing component positioned thereon.

The trialing scan data generated by the intra-operative trialing scansis transmitted by the hand-held device 110 to the computing device 140via the network 170. From the intra-operative trialing scans, thecomputing device 140 is configured to determine trialing feedback dataindicative of the position and the orientation of the orthopaedictrialing component on the patient's bone 810 (blocks 416 and 418).

As used in this application, “trialing feedback data” refers to any datagenerated during a trialing process performed during the orthopaedicsurgical procured. The trialing feedback data is generally indicative ofthe position and orientation of an orthopaedic trialing component on thebone 810 of a patient 180. For example, trialing feedback data mayinclude one or more images generated by the computing device 140 fromthe trialing scan data, data generated by a member of the surgical teamperforming the orthopaedic surgical procedure, other data generated bythe computing device 140 (including three-dimensional models), or anyother type of data generated during the trialing process of anorthopaedic surgical procedure. It should be appreciated that trialingfeedback data is not limited to data generated from the one or moreintra-operative trialing scans.

At block 420, a member of the surgical team operates the computingdevice 140 to compare the trialing feedback data to the surgical planincluding comparing the position and orientation of the orthopaedictrialing component to the planned final position and orientationincluded in the surgical plan (block 422). In the illustrativeembodiment, the computing device 140 superimposes the images generatedfrom the trialing scan data on images generated from the pre-operativescan data in the surgical plan showing the planned final position andorientation of the orthopaedic prosthetic component. The superimposedimages are output to members of the surgical team via display 152.

As shown in FIG. 10, the superimposed image output to the surgical teamby the computing device 140 may include a depiction of the actual size,position, and orientation of the orthopaedic component 1010 and adepiction of a planned position and orientation of the orthopaediccomponent 1012 in the bone 810 of the patient 180. While FIG. 10 onlyshows one superimposed image, a plurality of superimposed images may begenerated and output, where the plurality of superimposed imagesincludes a plurality of views and perspectives of the surgical area. Insome embodiments, the computing device 140 is configured to generate athree-dimensional model of the surgical region from data generatedduring the intra-operative trialing scans. The three-dimensional modelis then compared to a three-dimensional model included in the surgicalplan. The three dimensional model in the surgical plan may be generatedbased on pre-operative data, bone alignment data, and/or trialingfeedback data previously generated.

At block 424, a member of the surgical team determines whether theorthopaedic trialing component is the correct size given the conditionof the patient 180. Once an orthopaedic surgical procedure has begun asurgeon, or other surgical team member, may desire to adjust thesurgical plan based on information determined during the orthopaedicsurgical procedure. If a member of the surgical team determines that theorthopaedic trialing component is an incorrect size or type, at block426, a new orthopaedic trialing component is selected to be used inanother trialing process. At block 428, the surgical plan is adjusted toinclude an updated planned size of the orthopaedic prosthetic componentbased on the trialing feedback data.

If a member of the surgical team determines that the orthopaedictrialing component is the correct size and type, at block 430, a memberof the surgical team operates the computing device 140 to determinewhether the orthopaedic trialing component is positioned and oriented insuch a way that the surgeon is satisfied that a similarly situatedorthopaedic prosthetic component will meet the needs of the patient 180.Whether the position and orientation of the orthopaedic component willultimately meet the needs of the patient 180 may be included in thetrialing feedback data. Referring again to FIG. 10, the actual positionand orientation of the orthopaedic component 1010 (trialing component orprosthetic component) may be compared to the planned position andorientation of the orthopaedic component 1012 by superimposing theimages generated from the intra-operative trialing scans to imagesgenerated from the pre-operative data. The superimposed images areconfigured to provide a visual comparison between the planned and actualpositions of the orthopaedic components 1010, 1012.

If the orthopaedic trialing component is not positioned correctly, atblock 432, it is determined whether the position of the orthopaedictrialing component matches the position and orientation indicated in thesurgical plan. If the member of the surgical team determines that theorthopaedic trialing component is positioned and oriented as indicatedin the surgical plan, at block 434, the surgical plan is adjusted with anew planned final position and new planned final orientation based onthis trialing feedback data. After the surgical plan has been adjusted,or if the orthopaedic trialing component is not positioned according tothe surgical plan, the method 230 loops back to block 414 and theorthopaedic trialing component is repositioned to conform to the plannedposition and orientation of the orthopaedic prosthetic componentincluded in the surgical plan.

If the orthopaedic trialing component is positioned correctly, at block436, a member of the surgical team determines whether the trialingprocess is over. If the trialing process is not over, the member of thesurgical team determines what adjustments are needed before performingthe trialing process again. In the illustrative embodiment, the flowdiagram shows the method 230 looping back to block 414, but it should beunderstood that the method 230 could loop back to any step based on thetrialing feedback data based on the determinations made by the member ofthe surgical team using the surgical plan and the trialing feedbackdata.

Referring to FIGS. 6 and 7, a method 232 for implanting an orthopaedicprosthetic component and confirming that the position and orientation ofthe orthopaedic prosthetic component matches the surgical plan is shown.The method 232 for implanting an orthopaedic prosthetic component issimilar to the method 230 for performing a trialing procedure discussedabove.

At block 610, a member of the surgical team selects an orthopaedicprosthetic component (see, for example, orthopaedic component 1010 inFIG. 10) based on the surgical plan. The orthopaedic prostheticcomponent may be selected using pre-operative data, bone alignment data,trialing feedback data, or any combination thereof. Depending on theorthopaedic surgical procedure, a surgeon may not have collected all ofthe data listed above. For example, the orthopaedic prosthetic componentmight be selected only using pre-operative data and bone alignment data.

At block 612, the orthopaedic prosthetic component is positioned in theexposed bone 810 of the patient 180 is preparation to implant theorthopaedic prosthetic component permanently in the patient 180. Atblock 614, one or more intra-operative scans are are performed of theexposed bone 810 and the orthopaedic prosthetic component and implantfeedback data is generated. As used in this application, “implantfeedback data” refers to any data generated while implanting theorthopaedic prosthetic component in the patient 180 during theorthopaedic surgical procedure. The implant feedback data is indicativeof the position and orientation of an orthopaedic prosthetic componenton the bone 810 of a patient 180 (see block 616). For example, implantfeedback data may include implant scan data generated by theintra-operative implant scans, data generated by a member of thesurgical team performing the orthopaedic surgical procedure, datagenerated by the computing device 140 (including images orthree-dimensional models), or any other type of data generated duringthe implantation process of the orthopaedic prosthetic component duringan orthopaedic surgical procedure.

At block 620, a member of the surgical team operates the computingdevice 140 to compare the implant feedback data to the surgical planincluding comparing the position and orientation of the orthopaedicprosthetic component to the planned final position and orientationincluded in the surgical plan (block 622). At block 624, a member of thesurgical team determines whether the orthopaedic prosthetic component issized to meet the needs of the patient. For example, a surgeon maydetermine whether the orthopaedic prosthetic component will allow thepatient 180 the desired amount of movement, stability, and comfort.

If the member of the surgical team determines the orthopaedic prostheticcomponent is sized incorrectly, a new orthopaedic prosthetic componentis selected based on the implant feedback data (see block 626).Additionally, the surgical plan is also updated with the implantfeedback data and the new planned size of orthopaedic implant (see block628).

At block 630, a member of the surgical team determines whether theorthopaedic prosthetic component is positioned correctly based on theimplant feedback data. At block 632, a member of the surgical teamdetermines whether the orthopaedic prosthetic component is positionedaccording to the surgical plan. If the orthopaedic prosthetic componentis not positioned to meet the needs of the patient 180 and is notpositioned according to the surgical plan, the position and orientationof the orthopaedic prosthetic component is adjusted to conform to theplanned position and orientation included in the surgical plan. If theorthopaedic prosthetic component is not positioned to meet the needs ofthe patient 180 and is positioned according to the surgical plan, theplanned final position and orientation of the orthopaedic prostheticcomponent is adjusted based on the implant feedback data (see block634).

At block 636, a member of the surgical team uses the implant feedbackdata to confirm that the orthopaedic prosthetic component is implantedaccording to the surgical plan. Once the surgeon on the surgical team issatisfied that the orthopaedic prosthetic component is sized,positioned, and oriented correctly, the orthopaedic prosthetic componentis fixed in place relative to the bone 810 of the patient 180, the fullprosthetic is assembled, and the orthopaedic surgical procedure is movedtowards completion.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such an illustration and descriptionis to be considered as exemplary and not restrictive in character, itbeing understood that only illustrative embodiments have been shown anddescribed and that all changes and modifications that come within thespirit of the disclosure are desired to be protected.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the method, apparatus, and system describedherein. It will be noted that alternative embodiments of the method,apparatus, and system of the present disclosure may not include all ofthe features described yet still benefit from at least some of theadvantages of such features. Those of ordinary skill in the art mayreadily devise their own implementations of the method, apparatus, andsystem that incorporate one or more of the features of the presentinvention and fall within the spirit and scope of the present disclosureas defined by the appended claims.

1. A method of performing an orthopaedic surgery on a patient, themethod comprising: positioning the patient on a surgical table in anoperating room, making an incision in the patient's tissue to expose abone of the patient, obtaining a first scan with a hand-held device, thefirst scan including a position and an orientation of the bone in theoperating room, transmitting the first scan from the hand-held device toa computing device, operating the computing device to (i) compare theposition and the orientation of the bone included in the first scan to asurgical plan including a planned position and a planned orientation ofthe patient's bone and (ii) generate an adjusted planned position and anadjusted planned orientation of an orthopaedic prosthetic component inthe patient's bone based on the position and the orientation of the boneincluded in the first scan, implanting the orthopaedic prostheticcomponent in the bone of the patient, obtaining a second scan with thehand-held device, the second scan including a position and anorientation of the orthopaedic prosthetic component in the bone,transmitting the second scan from the hand-held device to the computingdevice, and operating the computing device to confirm that the positionand the orientation of the orthopaedic prosthetic component included inthe second scan matches the adjusted planned position and the adjustedplanned orientation of the orthopaedic prosthetic component.
 2. Themethod of claim 1, wherein obtaining the first scan further comprisespositioning an optical detector of the hand-held device inside of theincision formed in the patient's tissue, and performing the first scanwith the hand-held device.
 3. The method of claim 1, wherein obtainingthe first scan with the hand-held device further comprises obtaining thefirst scan with an optical detector positioned on the hand-held device,the optical detector being configured to detect electromagneticradiation reflected from a surface of interest on the patient.
 4. Themethod of claim 3, wherein the hand-held device is a white light scannerconfigured to determine one or more locations of a surface of intereston the patient by detecting one or more characteristics of white lightreflected from the surface of interest.
 5. The method of claim 3,wherein the hand-held device is a laser scanner that includes one ormore optical detectors configured to determine one or more locations ona surface of interest on the patient by detecting one or morecharacteristics of laser light reflected from the surface of interest.6. The method of claim 1, wherein when obtaining a scan of the patientthe patient is not moved to a new location and the position of thepatient relative to a reference plane is not modified.
 7. The method ofclaim 1, wherein operating the computing device further comprisesoperating the computing device to display a comparison of the positionand the orientation of the bone included in the first scan to thesurgical plan that includes the planned position and the plannedorientation of the patient's bone.
 8. The method of claim 1, whereinoperating the computing device further comprises operating the computingdevice to display a comparison of the position and orientation of theorthopaedic prosthetic component included in the second scan to thesurgical plan that includes the planned component position and plannedcomponent orientation of the orthopaedic prosthetic component in thepatient's bone.
 9. The method of claim 1, further comprising:positioning an orthopaedic trialing component in the bone of thepatient, obtaining a third scan with the hand-held device, the thirdscan including a first position and a first orientation of theorthopaedic trialing component, transmitting the third scan from thehand-held device to the computing device, and operating the computingdevice to determine trialing feedback data by comparing the firstposition and the first orientation of the orthopaedic trialing componentincluded in the third scan to the surgical plan that includes a plannedcomponent position and a planned component orientation of theorthopaedic prosthetic component.
 10. The method of claim 9, furthercomprising: adjusting the orthopaedic trialing component to be in asecond position and a second orientation in the bone of the patientbased on the trialing feedback data, obtaining a fourth scan with thehand-held device, the fourth scan including data related to the secondposition and the second orientation of the orthopaedic trialingcomponent, and operating the computing device to determine additionaltrialing feedback data by comparing the second position and the secondorientation of the orthopaedic trialing component included in the fourthscan to the surgical plan.
 11. The method of claim 9, furthercomprising: selecting a different orthopaedic trialing component basedon the trialing feedback data, positioning the different orthopaedictrialing component in the bone of the patient, obtaining a fifth scanwith the hand-held device, the fifth scan including a position and anorientation of the different orthopaedic trialing component,transmitting the fifth scan from the hand-held device to the computingdevice, and operating the computing device to compare the position andorientation of the different orthopaedic trialing component included inthe fifth scan to the surgical plan.
 12. A method of performing anorthopaedic surgery on a patient, the method comprising: positioning thepatient on a surgical table in an operating room, making an incision inthe patient's tissue to expose a bone of the patient, obtaining a firstscan with a hand-held device, the first scan including a position and anorientation of the bone in the operating room, transmitting the firstscan from the hand-held device to a computing device, operating thecomputing device to (i) compare the position and the orientation of thebone included in the first scan to a surgical plan including a plannedposition and a planned orientation of the patient's bone and (ii)generate an adjusted planned position and an adjusted plannedorientation of an orthopaedic prosthetic component in the patient's bonebased on the position and the orientation of the bone included in thefirst scan, positioning an orthopaedic trialing component in the bone ofthe patient based on the adjusted planned position and the adjustedplanned orientation, obtaining a second scan with the hand-held device,the second scan including a first position and a first orientation ofthe orthopaedic trialing component, transmitting the second scan fromthe hand-held device to the computing device, and operating thecomputing device to determine trialing feedback data by comparing thefirst position and the first orientation of the orthopaedic trialingcomponent included in the second scan to the surgical plan that includesa planned component position and a planned component orientation of theorthopaedic prosthetic component.
 13. The method of claim 12, furthercomprising: adjusting the orthopaedic trialing component to be in asecond position and a second orientation in the bone of the patientbased on the trialing feedback data, obtaining a third scan with thehand-held device, the third scan including data related to the secondposition and the second orientation of the orthopaedic trialingcomponent, transmitting the third scan from the hand-held device to thecomputing device, and operating the computing device to compare thesecond position and the second orientation of the orthopaedic trialingcomponent included in the third scan to the surgical plan.
 14. Themethod of claim 12, further comprising: selecting a differentorthopaedic trialing component based on the trialing feedback data,positioning the different orthopaedic trialing component in the bone ofthe patient, obtaining a fourth scan with the hand-held device, thefourth scan including a position and an orientation of the differentorthopaedic trialing component, transmitting the fourth scan from thehand-held device to the computing device, and operating the computingdevice to determining additional trialing feedback data by comparing theposition and orientation of the different orthopaedic trialing componentincluded in the fourth scan to the surgical plan.
 15. The method ofclaim 12, wherein positioning the orthopaedic trialing component in thebone of the patient is performed prior to implanting the orthopaedicprosthetic component in the bone of the patient, the method furthercomprising positioning the orthopaedic prosthetic component in the boneof the patient based on the trialing feedback data.
 16. The method ofclaim 12, wherein selecting the orthopaedic trialing component furthercomprises selecting a size of orthopaedic trialing component based onthe position and the orientation of the bone included in the first scan,the size of the orthopaedic trialing component being different than thesize of the orthopaedic trialing component specified in the surgicalplan.
 17. A method of performing an orthopaedic surgery on a patient,the method comprising: positioning the patient on a surgical table in anoperating room, making an incision in the patient's tissue to expose abone of the patient, positioning an orthopaedic trialing component inthe bone of the patient based on a surgical plan that includes a plannedposition, and a planned orientation, obtaining a first scan with ahand-held device, the first scan including a first position and a firstorientation of the orthopaedic trialing component, transmitting thefirst scan from the hand-held device to a computing device, operatingthe computing device to determine trialing feedback data by comparingthe first position and the first orientation of the orthopaedic trialingcomponent included in the first scan to the surgical plan, implanting anorthopaedic prosthetic component in the bone of the patient, obtaining asecond scan with the hand-held device, the second scan including acomponent position and a component orientation of the orthopaedicprosthetic component in the bone, transmitting the second scan from thehand-held device to the computing device, and operating the computingdevice to confirm that the component position and the componentorientation of the orthopaedic prosthetic component included in thesecond scan matches the planned position and the planned orientation ofthe orthopaedic prosthetic component.
 18. The method of claim 17,further comprising: operating the computing device to determine anadjusted position and an adjusted orientation based on the trialingfeedback data, implanting the orthopaedic prosthetic component in thebone of the patient in the adjusted position and in the adjustedorientation, and operating the computing device to confirm that thecomponent position and the component orientation of the orthopaedicprosthetic component included in the second scan matches the adjustedposition and the adjusted orientation.
 19. The method of claim 18,wherein the adjusted position determined from the trialing feedback datais different than the planned position included in the surgical plan andthe adjusted orientation determined from the trialing feedback data isdifferent than the planned orientation included in the surgical plan.20. The method of claim 17, wherein the surgical plan further includes aplanned prosthetic size, the method further comprising: selecting theorthopaedic trialing component based on the planned prosthetic sizeincluded in the surgical plan, operating the computing device to comparethe first position and the first orientation of the orthopaedic trialingcomponent included in the first scan to determine a new prosthetic size,and selecting the orthopaedic prosthetic component to implant in thebone of the patient based on the new prosthetic size.